Thyroid SurgeryNCT04982185
Neuromuscular Block Monitoring During Monitored Thyroidectomy
An observational study of Thyroid Surgery, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Titration of neuromuscular block (NMB) plays a key role in intraoperative recurrent laryngeal nerve monitoring during thyroid surgery. Aim to titrate sugammadex dose based on neuromuscular block degree as a surgeon friendly protocol with high intraoperative neuromonitoring (IONM) quality. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Surgery
- How many people
- 116 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In a tertiary medical center and a regional teaching hospital
Who may be able to join
- elective monitored thyroidectomy
Who cannot join
- previous thyroid surgery
- preexisting vocal cord palsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Routine Neuromuscular Block Monitoring During Monitored Thyroidectomy- A Retrospective Review
Titration of neuromuscular block (NMB) plays a key role in intraoperative recurrent laryngeal nerve monitoring during thyroid surgery. Aim to titrate sugammadex dose based on neuromuscular block degree as a surgeon friendly protocol with high intraoperative neuromonitoring (IONM) quality.
- Conditions
- Thyroid Surgery
- Keywords
- intraoperative neuromonitoring (IONM), thyroid surgery, neuromuscular block (NMB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Deep block | Deep neuromuscular block before initial (V1) vagal stimulation. | |
| Moderate block | Moderate neuromuscular block before initial (V1) vagal stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility in neural monitoring
EMG amplitude
Measured: through surgery completion, an average of 2 hours
Secondary outcomes (1)
Quality of surgical relaxation
patient movement assessed as severe, mild or none by a departmental scale (none=no movement, mild: any movement did not interfere operation, severe: any movement interrupt operation)
Measured: through surgery completion, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Aug 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Responsible party
- Principal investigator, I-Cheng Lu, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982185
- Sponsor's protocol ID
- KMUHIRB-E(I)-20210070
- Status last verified
- Oct 2021
- First submitted
- 20 Jun 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Routine Neuromuscular Block Monitoring During Monitored Thyroidectomy- A Retrospective Review
- ClinicalTrials.gov ID
- NCT04982185
- Acronym / sponsor ID
- KMUHIRB-E(I)-20210070
- Conditions
- Thyroid Surgery
- Keywords
- intraoperative neuromonitoring (IONM), thyroid surgery, neuromuscular block (NMB)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Titration of neuromuscular block (NMB) plays a key role in intraoperative recurrent laryngeal nerve monitoring during thyroid surgery. Aim to titrate sugammadex dose based on neuromuscular block degree as a surgeon friendly protocol with high intraoperative neuromonitoring (IONM) quality.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep block | – | –Deep neuromuscular block before initial (V1) vagal stimulation. |
| Moderate block | – | –Moderate neuromuscular block before initial (V1) vagal stimulation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In a tertiary medical center and a regional teaching hospital
Key inclusion criteria (1 listed)
- elective monitored thyroidectomy
Key exclusion criteria (2 listed)
- previous thyroid surgery
- preexisting vocal cord palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility in neural monitoring
Time frame: through surgery completion, an average of 2 hours
EMG amplitude
1 secondary outcome
Quality of surgical relaxation
Time frame: through surgery completion, an average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Surgery, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility in neural monitoring (time frame: through surgery completion, an average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.